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A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension in Juvenile Rheumatoid Arthritis (JRA/JIA)

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00279747
First received: January 19, 2006
Last updated: October 31, 2013
Last verified: October 2013

January 19, 2006
October 31, 2013
September 2000
January 2003   (final data collection date for primary outcome measure)
Response rates according to ACR Ped 30 [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]
Response rates according to ACR Ped 30
Complete list of historical versions of study NCT00279747 on ClinicalTrials.gov Archive Site
  • Global assessment of overall disease activity by investigator [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Parent global assessment of overall well-being [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Assessment of functional disability by means of Childhood Health Assessment Questionnaire (CHAQ) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Number of joints with active arthritis [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Number of joints with limited range of motion [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Erythrocyte Sedimentation Rate (ESR) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Parent global assessment of arthritis [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Parent global assessment of pain [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Children's assessment of discomfort [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Change in functional classification (Steinbrocker classification) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Final global assessment of efficacy by parent [ Time Frame: week 12, 12 months ] [ Designated as safety issue: No ]
  • Final global assessment of efficacy by investigator [ Time Frame: week 12, 12 months ] [ Designated as safety issue: No ]
  • Withdrawals due to inadequate efficacy [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Paracetamol / acetaminophen consumption [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Final global assessment of tolerability by parent [ Time Frame: week 12, 12 months ] [ Designated as safety issue: No ]
  • Final global assessment of tolerability by investigator [ Time Frame: week 12, 12 months ] [ Designated as safety issue: No ]
  • Incidence and intensity of adverse events (AEs) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence of laboratory adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Withdrawal due to adverse event [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Duration of hospital stay due to gastrointestinal serious adverse event (GI-SAE) [ Time Frame: week 12, 12 months ] [ Designated as safety issue: No ]
  • Duration of hospital stay due to adverse events related to trial drug administration [ Time Frame: week 12, 12 months ] [ Designated as safety issue: No ]
  • Additional visits to a physician due to gastrointestinal adverse event (GI-AE) [ Time Frame: week 12, 12 months ] [ Designated as safety issue: No ]
Investigator global assessment of overall disease activity, parent global assessment of overall well-being, number of joints with active arthritis, number of joints with limited range of motion, assessment of functional disability by means of CHAQ
Not Provided
Not Provided
 
A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension in Juvenile Rheumatoid Arthritis (JRA/JIA)
A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension 0.25mg/kg and 0.125 mg/kg Administered Once Daily in Comparison to Naproxen Oral Suspension 5mg/kg Administered Twice Daily in Children With Juvenile Rheumatoid Arthritis.

A one year double-blind trial to investigate the efficacy and safety of meloxicam oral suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis.

Objective: In an international, multicenter, double-blind, randomized clinical trial we evaluated the short-term (3 months) and long term (12 months) efficacy and safety of two doses of meloxicam oral suspension compared with naproxen in children with oligo and polyarticular course juvenile idiopathic arthritis (JIA).

Methods: Children with active oligo or polyarticular course JIA, requiring therapy with an NSAID were eligible for this trial. Patients were randomly allocated to therapy with meloxicam oral suspension 0.125 mg/kg body weight in single daily dose, meloxicam 0.25 mg/kg body weight in single daily dose, or naproxen 10 mg/kg body weight in two daily doses. The trial drugs were administered in a double-blind, double-dummy design for up to 12 months. Response rates were determined according to the American College of Rheumatology Pediatric 30% definition of improvement (ACR Ped 30). Safety parameters were assessed by evaluation of the adverse events in the 3 groups.

Study Hypothesis:

The null hypothesis of interest is that the magnitude of response with regard to the primary endpoint is equivalent between the treatment groups. The alternative is that there is any difference (two-sided) between any of the treatment groups.

Comparison(s):

Naproxen oral suspension 10 mg/kg body weight.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Arthritis, Juvenile Rheumatoid
  • Drug: meloxicam 0.25 mg/kg
  • Drug: meloxicam 0.125 mg/kg
  • Drug: naproxen 10 mg/kg
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
226
January 2003
January 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female outpatients and inpatients aged 2 to 16 years
  • Diagnosis of idiopathic arthritis of childhood by ILAR criteria:

    • Age of onset less than 16 years
    • Arthritis in one or more joints defined as swelling, or - if no swelling is present - limitation in range of joint movement with joint pain or tenderness, which is not due to primary mechanical disorders
    • Duration of the disease > 6 weeks
    • Type of onset of disease during the first 6 months classified as polyarthritis (5 joints or more; rheumatoid factor positive or negative), oligoarthritis (4 joints or fewer) or systemic arthritis
  • Oligoarthritic, extended oligoarthritic or polyarthritic current course of disease
  • Active arthritis as defined above of at least 2 joints
  • At least 2 other abnormal variables of any of the 5 remaining core set parameters. The physician and the parent ratings must be at least 10 mm on a 100 mm VAS scale and the CHAQ score more than 0.
  • Patients requiring therapy with NSAIDs, i.e., the patient fits into one of the following categories:

    • New onset patient
    • Patient in remission, but experiencing a flare and now requiring an NSAID
    • Patient with insufficient therapeutic effect (ITE) or intolerability to another NSAID (other than Naproxen) and now must be changed
  • Written informed permission given by the parent(s) or the subjects legally authorised representative in accordance with local legislation and ICH GCP
  • Active assent given by the patient if the child is capable of understanding the given information (applies to children who have reached an intellectual age of 7 years or greater)

Exclusion Criteria:

  • Patients with systemic course of JRA (intermittent fever with or without rash or other organ involvement) or with current systemic involvement
  • All rheumatic diseases not covered by the inclusion criteria
  • Any finding indicating that the patient has a clinically significant other disease than JRA at the time of enrollment
  • Patients with abnormal, clinically relevant laboratory values not related to their JRA
  • Pregnancy or breast feeding
  • Women of childbearing potential not using adequate contraception precaution: attention should be drawn to reports that NSAIDs were reported to decrease the effectiveness of intrauterine devices (R95-0164)
  • History of bleeding disorders, gastrointestinal bleeding or cerebrovascular bleeding
  • Active peptic ulcer within the last 6 months
  • Treatment with more than one SAARD/DMARD (slow-acting antirheumatic drug/disease-modifying antirheumatic drug) during the last 3 months prior to study entry
  • Change in treatment with SAARDs/DMARDs during the last 3 months prior to study entry or intended change during the trial duration
  • Change in treatment with corticosteroids during the last month prior to study entry or intended change during the trial duration with exception of local therapy for uveitis
  • One of the following therapies during the last 3 months prior to study entry or their intended use during the trial treatment period

    • Systemic treatment (except for intra-articular injections) with corticosteroids at a dose higher than 10 mg/day or 0.2 mg/kg/day (prednisone equivalent), respectively (whichever is lower)
    • Treatment with hydroxychloroquine at a dose higher than 10 mg/kg/day
    • Treatment with cyclosporine at a dose higher than 5 mg/kg/day
    • Treatment with methotrexate at a dose higher than 15 mg/m2/week
    • Treatment with other cytotoxic agents, gold compounds, D-penicillamine, Enbrel (etanercept), biologic agents and experimentals
  • Intra-articular injections of corticosteroids during the last month prior to study entry and intended injections during the first 4 weeks of the trial treatment period
  • Concomitant administration of other NSAIDs (including topical forms for skin with exception of local therapy for uveitis) or analgesic agents except paracetamol or acetaminophen
Both
2 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   France,   Germany,   Italy,   Russian Federation,   United Kingdom
 
NCT00279747
107.208
Not Provided
Not Provided
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Pharma GmbH & Co. KG
Boehringer Ingelheim
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP